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Firibastat in Treatment-resistant Hypertension (FRESH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04277884
Recruitment Status : Completed
First Posted : February 20, 2020
Last Update Posted : October 20, 2022
Sponsor:
Information provided by (Responsible Party):
Quantum Genomics SA

Study Description
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Brief Summary:
This is a double-blind, placebo-controlled, multicenter, efficacy and safety study of firibastat (QGC001) administered po bid over 12 weeks in male and female subjects ≥18 years of age at Screening, with uncontrolled primary HTN. Subjects will be randomized 1:1 to investigational product (IP) and will receive either firibastat (QGC001) or matching placebo on top of their current chronic antihypertensive treatments.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Firibastat Drug: Placebo Phase 3

Detailed Description:
The primary objective of this study is to assess the effects of administration of firibastat (QGC001) 500 mg oral (po) twice daily (bis in die [bid]) on blood pressure (BP) over 12 weeks in subjects with uncontrolled primary HTN.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 515 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-blind, Placebo-controlled, Efficacy and Safety Study of Firibastat (QGC001) Administered Orally, Twice Daily, Over 12 Weeks in Difficult-to-treat/Resistant Hypertensive Subjects
Actual Study Start Date : June 25, 2020
Actual Primary Completion Date : August 30, 2022
Actual Study Completion Date : September 20, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Firibastat
Capsules
 Drug: Firibastat
Oral administration 2×250 mg capsules bid
Other Name: QGC001
Placebo Comparator: Placebo
Matching capsules
 Drug: Placebo
Oral administration 2 capsules bid


Outcome Measures
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Primary Outcome Measures :
  1. Systolic Blood Pressure at office (mmHg) [ Time Frame: From Day 1 to Day 84 ]
    Automatic Office Blood Pressure measurement


Secondary Outcome Measures :
  1. Diastolic Blood Pressure at office (mmHg) [ Time Frame: From Day 1 to Day 84 ]
    Automatic Office Blood Pressure measurement

  2. Mean 24-hour ambulatory Systolic Blood Pressure (mmHg) [ Time Frame: From Day 1 to Day 84 ]
    Ambulatory Blood Pressure Monitoring

  3. Mean 24-hour ambulatory Diastolic Blood Pressure (mmHg) [ Time Frame: From Day 1 to Day 84 ]
    Ambulatory Blood Pressure Monitoring


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women ≥18 years of age at Screening
  • Diagnosis of primary HTN for at least 6 months prior to Screening

Exclusion Criteria:

  • Known or suspected secondary HTN (eg, hyperaldosteronism, renovascular HTN, pheochromocytoma, Cushing's disease).
  • Automated office SBP >180 mmHg or DBP >110 mmHg at the Screening or Inclusion Visit (Visit 2, Day 1) and confirmed by a second measurement within 30 minutes to 1 hour.
  • Known hypertensive retinopathy (Keith-Wagener Grade 3 or Grade 4) and/or hypertensive encephalopathy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04277884


Locations
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Sponsors and Collaborators
Quantum Genomics SA
Investigators
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Principal Investigator: George Bakris, MD AHA Comprehensive Hypertension Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Quantum Genomics SA
ClinicalTrials.gov Identifier: NCT04277884    
Other Study ID Numbers: QGC001-3QG1
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: October 20, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Firibastat
Antihypertensive Agents